The intravenously administered taxanes, docetaxel and paclitaxel, alone and in combination with other chemotherapy agents are active in patients with advanced and metastatic bladder cancer, and agents of this class are a promising treatment option for some patients.

Tesetaxel is an orally administered taxane that is in development as treatment for subjects with advanced cancers. This study is being conducted to determine the efficacy and safety of tesetaxel administered to patients previously treated with chemotherapy for progressive metastatic transitional cell carcinoma of the urothelium.

Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months

In Cycle 1, a dose of 27 mg/m2 will be administered. In subsequent cycles,

the dose will be increased to 35 mg/m2 in Cycle 2 for subjects who did not have an ANC < 1,500/mm3, a platelet count < 100,000/mm3, or a Grade 3 (or higher grade) nonhematologic adverse event considered by the Investigator to be related to protocol therapy (excluding alopecia, nausea, and vomiting) in Cycle 1. The dose is not to exceed the dose of 35 mg/m2 in any cycle subsequent to Cycle 2.

for all other subjects, the dose administered in Cycle 1 (27 mg/m2) will be administered in all subsequent cycles.

Previously treated with not more than 1 doublet or triplet regimen and that regimen contained gemcitabine and a platinum agent

Adequate bone marrow, hepatic, and renal function, as specified in the protocol

At least 4 weeks and recovery from effects of prior surgery, prior radiotherapy, or other therapy with an approved or investigational agent

Ability to swallow an oral solid-dosage form of medication

Exclusion Criteria:

Known metastasis or symptoms of metastasis to the central nervous system

Significant medical disease other than cancer

Presence of neuropathy > Grade 1 (NCI CTC, Version 4.0)

Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid

Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215877